Date: 2016-01-12
Type of information: Licensing agreement
Compound: AlloMap®
Company: Diaxonhit (France) CareDx (USA - CA)
Therapeutic area: Transplantation - Cardiovascular diseases
Type agreement: licensing
commercialisation
Action mechanism: AlloMap® test uses a blood sample to help doctors manage the care of stable heart transplant recipients. The test is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap test score - an integer ranging from 0 to 40. Compared with patients in the same post-transplant period, the lower the score, the lower the probability of acute cellular rejection at the time of testing. About AlloMap®
AlloMap Molecular Testing is intended to aid in the identification of heart transplant recipients with stable allograft
function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in
conjunction with standard clinical assessment. AlloMap is performed in the CLIA-certified and CAP-accredited clinical
laboratory at CareDx and has been commercially available in the United States since 2005. AlloMap was cleared by the
U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Recommended use of
AlloMap for heart transplant rejection surveillance is included in the International Society for Heart and Lung
Transplantation (ISHLT) Guidelines for the care of heart transplant recipients, published in August, 2010. These
guidelines represent the worldwide standard for the care of heart transplant patients.
Disease:
Details: * On June 4, 2013, Diaxonhit, a French provider of specialty diagnostic solutions, and CareDx, Inc., a U.S. molecular diagnostics company focused on non-invasive tests for transplantation and autoimmune disease, have entered into a memorandum of agreement for the exclusive license to market and perform AlloMap Molecular Expression Testing (AlloMap®) in Europe. AlloMap is CareDx\'s diagnostic blood test used by physicians to identify heart transplant recipients who have a low probability of acute cellular rejection. AlloMap has been marketed in the United States since 2005 and is CLIA certified, FDA cleared and obtained CE marking in Europe in 2011.
Through its wholly owned subsidiary, InGen, a leader in France for marketing tests related to transplantation, Diaxonhit has a dedicated sales force and access to an extensive commercial network throughout Europe. The group will build on these assets to promote AlloMap. In Europe, the AlloMap test will be performed centrally by an internationally recognized French laboratory that is a leader in the field of molecular immunology and histocompatibility testing.
Financial terms: In return for this exclusive European license, XDx will receive an upfront payment upon signature of the definitive agreement, future royalties based on European sales, and milestone payments based on sales performance. These payments will be made in cash and Diaxonhit stock. Payment in stock will be subject to a specific resolution to be submitted to Diaxonhit’s shareholders for their approval at the upcoming Annual General Meeting to be held on June 20, 2013.
Latest news: * On January 12, 2016, CareDx and Diaxonhit announced the completion of the transfer of the CareDx proprietary AlloMap gene expression test into the Strasbourg University Hospital Central Immunology Laboratory (HUS) in France. This multi-step validation process has demonstrated that AlloMap test results released from the HUS laboratory are equivalent to AlloMap results generated by the CareDx main laboratory in the United States. With the completion of this technology transfer, patient samples can now be tested at HUS. This transfer is a significant milestone for CareDx and its exclusive European licensee and commercial partner, Diaxonhit, which contracted with Strasbourg University Hospital in 2014 to be the dedicated testing laboratory for AlloMap throughout Europe. Diaxonhit has utilized its expertise in transplantation to design health economic studies for AlloMap reimbursement in Europe. The French Ministry of Health has recently approved the funding of a study designed to demonstrate that AlloMap is non-inferior to biopsy to inform about the risk of acute cellular rejection among French heart transplant patients. * On January 12, 2015, Diaxonhit announced that it entered into a service sub-licensing agreement with the Strasbourg University Hospitals (Hôpitaux Universitaires de Strasbourg, HUS) for the performance of the CareDx AlloMap® test in a dedicated facility as its Central European Laboratory. Under this agreement, all testing activities will be performed in HUS’ Central Immunology Laboratory, under the authority and exclusive responsibility of HUS and its scientific director, Professor Seiamak Bahram. The AlloMap molecular blood test is a novel method for regular and non-invasive surveillance of heart transplant recipients for acute cellular rejection. All patients’ blood samples collected in heart transplant centers around Europe will be shipped to the Strasbourg facility where the AlloMap testing procedure will be performed. Test results will be sent back directly from the Central Laboratory to the clinicians, consisting primarily of cardiologists and heart surgeons. Diaxonhit will supply the central laboratory with specific AlloMap plates and control reagents both manufactured by CareDx. The french company will also supply heart transplant centers with a kit to facilitate blood samples handling and shipment. * On July 1, 2014, CareDx and Diaxonhit announced that CareDx has successfully tested its first European AlloMap commercial sample, which was shipped directly from Transplantationszentrum München, a leading transplant hospital in Munich, Germany, to the clinical laboratory at CareDx in Brisbane. Through its European commercial partner, Diaxonhit, CareDx has established an exclusive distribution channel for AlloMap in the European Union. This reported test represents the first commercial result rendered in Europe. CareDx and Diaxonhit are currently working on plans for the AlloMap test to be performed directly in Europe through an exclusively licensed laboratory.
HUS’ Central Immunology Laboratory was selected by Diaxonhit for its ability to conduct the testing procedure with all necessary quality requirements to ensure the accuracy and reproducibility of AlloMap results delivered to prescribing clinicians. Under the leadership of Professor Seiamak Bahram who is also director of TRANSPLANTEX, a French government funded “Laboratory of Excellence” (LabEx), this laboratory is at the forefront in the fields of transplantation and histocompatibility in Europe. A dedicated team of seasoned technical staff and biologists will perform the AlloMap procedure within a well-defined environment, including specific instruments that are currently being implemented. Staff training will be initiated soon by Diaxonhit and CareDx in order for the laboratory to become operational during the first half of 2015.
